Moving from efficacy to safety: A changing focus in the study of Asian medical systems.

Gerke, Asian medical systems

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MOVING FROM EFFICACY TO SAFETY:

A CHANGING FOCUS IN THE STUDY OF ASIAN MEDICAL SYSTEMS

BARBARA GERKE

After living and studying in India for a decade, I enrolled in the Master’s course in

Medical Anthropology at Oxford in 2002 as one of twelve students from five

countries. Studying at Oxford was such an inspiring experience that I continued

with a D.Phil. in Social Anthropology, researching longevity practices and

concepts of the life-span in Tibetan societies in India (Gerke 2012a). I then taught

at three universities in the USA and Germany, and pursued a post-doc at the

Humboldt University, Berlin, on detoxification methods in Tibetan pharmacology

and on how ideas of toxicity are translated cross-culturally (2011-2015). Critical

course discussions that we had at Oxford on efficacy made me look at issues of

safety and helped me think anthropologically about toxicity. How can we study

toxic ingredients of medicines with research methods specific to anthropology in

the absence of laboratories and biomedical testing tools? Looking at changing

anthropological approaches to efficacy and safety are my entry points for this

article, which provides some of the groundwork necessary to address questions of

how Tibetan doctors translate their ideas of toxicity and detoxification to a

Western audience.

Introduction

In relation to my postdoctoral project on concepts of toxicity and purification in Tibetan

medicine, I have come to re-think issues of ‘efficacy’ and ‘safety’ that we discussed during

the medical anthropology course at Oxford in 2002/03. I asked myself how these issues have

been dealt with in the discipline since then and how they have affected Asian medical

traditions.1 While reading through the literature, I noticed a certain shift of focus from

‘efficacy’ towards ‘safety,’ which I will discuss in this paper, specifically in relation to

toxicity in Tibetan medicine.

1 The German Research Foundation (DFG Project No. 53307213) kindly funded this research.


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Efficacy was not of primary interest in early medical anthropology, but it has become

so more recently, as was evident in the syllabus of the Master’s course in Medical

Anthropology at Oxford in 2002. In the late 1980s, efficacy was listed as the fifth main theme

in pharmaceutical anthropology (van der Geest 1988: 331). At that time, efficacy studies

mainly focused on double-blind randomized control trials (RCTs) and placebo studies (ibid.:

343-6). In the Master’s course, we analysed RCTs in order to understand how they culturally

determine efficacy. RCTs also highlight how profession-specific understandings of efficacy

are. In ethnopharmacology, efficacy was considered ‘the organizing paradigm perhaps most

central to ethnopharmacology’ (Etkin 1993: 99). During the Master’s course, we learnt that

‘therapeutic intentions are culturally constructed, even such seemingly objective aspects as

“efficacy”’ (ibid.: 100). We were trained to be aware of the complexities surrounding

efficacy, knowing that—to take one of Etkin’s examples—‘one cannot evaluate in the

laboratory the efficacy of a plant used against swelling due to infection in the same

way that one evaluates a plant used to treat swelling caused by witchcraft’ (ibid.). As

anthropologists, we were also made aware that pointing out efficacy as a ‘cultural artefact’ to

health planners has often been the ‘thankless task of the anthropologist’ (van der Geest 1988:

346).

My thought process was partly inspired by the new interdisciplinary collaboration

between ethnobotanists and medical anthropologists, visible in recent publications such as

Plants, Health and Healing (Hsu and Harris 2010). In her introduction to this book, Hsu

observes that so far the anthropology of pharmaceuticals has not focused on the ‘materiality

of drugs,’ but rather on meaning, socio-economic and cultural interpretation, symbolic

efficacy and social efficacy (Hsu 2010: 23). I agree with her critique that ‘the pharmaceutical

anthropologists have left the study of physiological efficacy to biomedicine’ and have instead


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‘accounted for socio-cultural aspects’ (ibid.). In the following, I will look at the importance

of physiological efficacy for anthropological studies on pharmacology in more detail.

My current research project investigates Tibetan medical ideas of toxins/poisons (Tib.

dug) and how Tibetan pharmacologists explain the detoxification (Tib. dug ’don)2 of

substances. These ideas are often expressed in terms of whether their detoxified medicines

are ‘safe,’ especially when ingredients involve poisonous plants, mercurial compounds, or

other metals. The safety concern is not so much an issue within Tibetan medical communities

themselves, where through experience these medicines are thought to be ‘safe,’ but is framed

as part of their interactions with biomedical standards and demands, as well as Tibetan

interests in exporting their medicines to countries where their ‘detoxified’ ingredients might

be considered ‘unsafe.’

How can anthropologists study the physiological efficacy and safety of such

detoxified Tibetan medicines? So far, they have studied the political efficacy of detoxified

Tibetan pills and how these medicines are employed to strengthen Tibetan identity in exile

(Kloos 2012). Widespread Tibetan practices of poisoning, which involve ideas of stealing the

life-force and fortune of the person who is being poisoned, have been ethnographically

researched (da Col 2012). However, we know little of what is considered a dug in Tibetan

pharmacology and how it affects the physiology of the body, especially from a Tibetan

medical perspective, which does not strictly follow organ-related ideas of efficacy, but views

the body in terms of balancing elements and ‘humours.’ When it comes to dug, physiological

efficacy seems to be inevitably linked to issues of toxicity and safety, which were not

emphasised in pharmaceutical anthropology until recently.

2 Processes of dug ’don largely involve the cleaning of raw materials by removing those parts that are either

considered harmful or even poisonous, and those parts that would interfere with or reduce the efficacy of the

beneficial parts.


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The move towards ‘safety’ and what it implies

Over the past decade, it seems that safety has been given a stronger emphasis than efficacy by

the WHO and in literature on ‘traditional’ medicine. To understand this shift, first we need to

analyse what ‘safety’ entails in so-called ‘traditional medical systems,’ which in most

cases—taking into account today’s globalized world and heterogeneous clinical modes—can

hardly be called ‘traditional’ anymore. The complex of ‘Tibetan medicine’ serves as one

example here for the development of a medical system in which the borders between

‘traditional’ and ‘modern’ have become very fluid, also influencing the ways in which

contemporary Tibetan doctors translate and negotiate biomedical concepts within their

‘traditional’ epistemologies and vice versa. Such increasing heterogeneity also affects

practitioners’ perceptions of safety.

There is a widespread perception, if not misconception, that ‘traditional’ remedies are

‘safer’ because they are ‘natural’ (Elvin-Lewis 2001: 141), assuming an almost essentialist

version of ‘safety’ directly linked to the highly constructed notion of ‘nature’. However, this

presumption is being increasingly scrutinized. I have seen Tibetan doctors warning patients

that their ‘natural’ remedies can be ‘unsafe’ and cause adverse effects if wrongly

administered.

There are a variety of conditions that influence what makes a substance ‘toxic’ and

‘unsafe’ in a certain context. Safety is not only a matter of efficacious ingredients or toxicity.

The Master’s programme at Oxford discussed safety in the context of the biological and

social aspects of drug-taking, showing how this inevitably leads to varying perceptions of

safety. We were made aware of the situatedness and the reasons why, for example,

pharmaceuticals are perceived as more risky than traditional medicines. One reason that


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traditional Asian medicine is considered safer is that it matches an individual’s prescription

with his/her constitution. It is thus a ‘personalized medicine,’ as is characteristic of Ayurveda,

Tibetan and Chinese medicine, and which is becoming increasingly popular.3

This kind of ‘situatedness of safety’ does not necessarily feature in the list of herbal

medicine safety issues identified by the WHO, namely contamination with heavy metals and

other hazardous substances, adulteration, wrong substitution, incorrect dosing and interaction

with other medicines (WHO 2004: 2). Below are a few examples of each of these points, and

to this list I would add two more: i) ‘traditional processing methods,’ of which we know little

and which are essential to understand emic explanations of safety; and ii) issues of

commodification and economic expansion. Moreover, safety is also defined by political

circumstances that influence these WHO safety guidelines (and why certain topics are

included and others are left out), which might neglect or even contradict localized perceptions

of safety.

Contamination is one of the safety issues linked to Good Manufacturing Practices

(GMP). GMP practices are indirectly concerned with toxicity because they aim at clean

manufacturing, the main aim being the avoidance of contamination, e.g. with heavy metals.

For example, a long-term intake of herbs contaminated with heavy metals can have toxic

effects.

Substitution. Misidentification of plants can lead to toxicity. The fact that the

erroneous substitution of one plant for another can cause toxic effects was shown in the case

of Chinese Herb Nephropathy (CHN) caused by a Chinese weight-reducing pill made with

the wrong substitutes (Hsu and Barrett 2008: 354).

3 This is evident, for example, from conferences, such as that on ‘The quest for personalised health: exploring

the emergent interface of East Asian medicines and modern system sciences’ organized by the EASTmedicine

Research Centre at the University of Westminster and the School of Life Sciences, June 2011.


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Dosage. Safety is situational: a substance can be efficacious at a certain dosage and

toxic at another. Long-term intake or over-dosage of herbal medicines can make them toxic.

Some Tibetan doctors resist the commercialization of Tibetan medicine as over-the-counter

products precisely because, through self-medication, the dosage might not correspond to the

individual constitution of the patient and could cause adverse effects.

Interaction with other medicines. Relationships between ingredients can influence

the overall toxicity and efficacy of a drug. For example, Tibetan medicinal plants tend to be

given in combination with other substances, not in isolation. Tibetan doctors I interviewed

consider single ingredients ‘toxic’ and unsafe, while in combination they are considered more

‘efficacious,’ since one substance can disarm the potential toxic effect of another. When

herbal preparations are combined with biomedical drugs—something patients tend to do

frequently in pluralistic medical settings—their physiological interactions can cause toxicity

(e.g. Elvin-Lewis 2001: 156).

‘Traditional’ processing methods. In Tibetan pharmacology, cleaning raw medicinal

materials, such as removing the bark or a kernel, is considered a part of ‘detoxification,’ since

these materials—also called dug, although they are not considered poisonous—are more

difficult to digest and would reduce the efficacy of the potent part of the plant. Mercury (Tib.

dngul chu), which is known to have three types of dug and is considered highly poisonous,

has to be transformed into a mercury sulphide ash through elaborate processes in order to be

considered ‘safe.’ This is similar to Ayurvedic and Chinese practices of using mercury almost

exclusively in the much less toxic, largely insoluble forms of mercury sulphide. In Tibetan

medicine, toxicity is also explained in terms of digestion. Tibetan doctors diagnose and treat

the digestive strength of a patient who has been affected by a dug, since they think that the


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ability to handle dug depends on the power of one’s digestion. The stronger one’s digestive

power, the better one’s ability to handle a dug.

Commodification and economic expansion. For countries where ‘traditional

medicine’ is a national asset, such as China, safety is also an issue of economic expansion;

China wants to play a significant role in the commodification and globalization of traditional

Chinese medicine (TCM) and is therefore pushing for the regulation of Chinese medicinal

substances. This economic expansion is also evident in the ways in which hospital

pharmacies throughout Tibet have been converted into pharmaceutical companies, producing

commodities for a nationwide market (Saxer 2013). In support of such expansions, the

Chinese Pharmacopoeia Committee has reduced the permissible amount of mercury and

arsenic used in Chinese medicine recipes twice in recent years (Wu et al. 2008: 839).

However, Chinese manufacturers do not necessarily follow GMP guidelines when it comes to

profitable medicines, such as Tibetan ‘precious pills’ (Tib. rin chen ril bu), which contain

mercury sulphide. Some of the mercury sulphide-containing compounds are considered

‘national heritage drugs’ and have so far remained outside GMP regulations (Saxer 2013: 74).

These examples show that safety is situational as well as multi-dimensional and that it

is increasingly becoming a major concern. Anthropological studies of safety, while they

cannot be seen in isolation from ideas of efficacy, should address such issues by unravelling

their linkages to local and global settings.

Links between safety, toxicity and ‘rejuvenating’ tonics

Why is it that across Asia toxic substances are often considered vitalizing? In Indian

alchemical and Ayurvedic contexts, mercury is attributed with rejuvenating properties as

reflected in its mythological and tantric correspondence to Shiva’s semen, though it is only


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potent in combination with sulphur, which symbolizes his consort’s blood. One of my

research aims has been to uncover the rationale behind Tibetan practices with mercury and

their inherent assumption that mercury is especially vitalizing when it is ‘tamed’ and

transformed into the most potent rejuvenating elixir (Gerke, in press)

While it could be argued that use of the term ‘rejuvenation’ is a modern esoteric

concept—often used for commercial purposes—it is important to know that rejuvenation is

also an articulated aim in some Asian medical practices. That does not mean that taking

‘longevity pills’ necessarily leads to a long life. For example, in medieval China, Tang

ascetic intake of ‘longevity pills’ was thought to lead to immortality through self-poisoning

(Hsu and Barrett 2008: 355). However, Tibetan medical texts on ‘treating the aged’ (rgas pa

gso ba) list vitalizing drugs and clearly articulate their rejuvenating effects. Tibetan technical

terms that are employed in such longevity contexts usually have a variety of other meanings

as well, but tend to be translated in terms of ‘rejuvenation.’ For example, the term chulen

(bcud len), which literally means ‘essence extraction,’ refers to pills made from extracts of

stones, flowers, minerals, etc. While such extractions have been used to prevent ageing and

revitalize the body, they also have significant religious, pharmacological and nutritional

meanings and purposes. Nevertheless, the term chulen and concepts surrounding it have

recently been re-invented in a process to market over-the-counter ‘rejuvenating tonics’

(Gerke 2012b).

‘Rejuvenating’ products touch on issues of safety precisely because they often contain

what we relegate to the realms of toxicity. In Asia, they usually contain higher levels of

heavy metals than other supplements. One study of Ayurvedic rasaśāstra ‘rejuvenating’

supplements sold online in the US showed that they contained the largest amount of metals

among the surveyed supplements, i.e. 40 percent; 20.7 percent of the samples were found to


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have potentially toxic levels of lead, arsenic or mercury (Saper et al. 2008: 918). However,

one major shortcoming of Saper’s study is that the investigators do not differentiate between

the types and ‘chemical species’ of heavy metals used. Talking simply about ‘mercury’

sounds alarming and glosses over the fact that it is mostly used in the form of mercury

sulphide, of which, once ingested, less than 0.2 percent is absorbed by the body (Liu et al.

2008: 813). The problem is that there are hardly any studies on the different ‘chemical

species’ of metals used in rasaśāstra, something the authors themselves acknowledge (Saper

et al. 2008: 922) but fail to include in their methodology. When it comes to mercury, this is a

significant lapse, since the absorption of mercurials by the body—and thus their

‘physiological efficacy’—varies from 0.2 to 95 percent, depending on their chemical form

(Liu et al. 2008: 813). Recently, some scientists have moved towards analysing the ‘chemical

species’ of metal ingredients in traditional medicines. One Chinese study, which uses cell

cultures to determine levels of toxicity, argues that the ‘chemical forms of metals are an

important factor in determining their toxicity in traditional medicines’ and that, for example,

both cinnabar (red mercury sulphide, HgS) and realgar (red arsenic, As4S4) ‘are much less

toxic than well-known mercurial and arsenicals’ (Wu et al. 2011: 839). While such studies

give a more nuanced perspective on the physiological efficacy of mercurial medicines, they

do not satisfy hard-core science toxicity regulations.

Tibetan pharmacologists have told me that the medicinal ‘power’ (nus pa) of mercury

is enhanced when properly ‘purified’ (dug ’don) and ‘tamed’ (’dul) through elaborate

pharmacological processing methods. Its ash mixture is then added as a base material to other

medicines, such as some ‘precious pills.’ These ‘precious pills’ are not only considered

necessary to treat severe, especially ‘modern’ diseases, but are equally popular as

‘rejuvenating’ tonics or talismans among Tibetans and more recently also Chinese, due to the


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additional blessed substances they contain. Moreover, because of their ‘precious’ ingredients,

they are more costly and time-consuming to produce, require specialized pharmacological

knowledge that few possess, and are therefore sold at higher prices than basic herbal

remedies. Thus, ‘precious pills’ form the pinnacle of Tibetan pharmacological knowledge and

increase the prestige of the institution and doctors who are able to manufacture them (Kloos

2012). While medical practitioners consider these pills their strongest therapeutic tools,

patients perceive them as an embodiment of vitality, health and ritual blessings.

These examples from my research highlight the interrelationships between toxic

ingredients and profitable manufacturing practices of contemporary ‘rejuvenating tonics’.

The politics of toxicity and safety

Kadetz concluded from his research on traditional medicines in the Philippines that safety is

not a universal concept, but perceived variously within local practices. ‘The predominant

sentiment was that unless a local practitioner gives one reason for concern, there is no

conception of risk with local practices’ (Kadetz 2014: 87). While the concept of risk is often

framed differently locally – for example, in terms of ‘fortune’, ‘luck,’ or ‘fate’ – it becomes a

global issue when pharmaceuticals are sold abroad and are found not to meet the required

safety standard, often because of toxicity concerns. Therefore, Tibetan doctors in India have

invited foreign scientists to analyse the safety of their mercury sulphide-containing ‘precious

pills’ (e.g. Sallon et al. 2006); they have confidence in their processing methods and consider

them safe, but they need ‘scientific evidence’ for trading with the outside world (Gerke

2013).

The WHO has mentioned the term ‘safety’ with great frequency in its publications

since the Traditional Medicine Unit came under the Department of Essential Medicines of the


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WHO, which attests to an increasing effort to control and define what is safe in non-

biomedical practices, also paralleling the growing commodification of the herbal industry in

Asia (Kadetz 2014: 85). When it comes to toxicity, to date WHO guidelines mention toxic

metals only in the context of contamination; as far as I know their widespread use as

medicinal ingredients, especially in Asian medicines, has yet to be addressed. This shows

that, on the one hand, the WHO is keen to define and control what is considered ‘safe,’ while

on the other it reduces the use of some ‘detoxified’ substances in non-biomedical practices to

issues of contamination without inquiring into their potential efficaciousness. Similarly, in

the UN’s legally binding treaty to ban mercury, passed in 2013—in itself meaningful—the

medicinal use of much less toxic mercury sulphide (cinnabar) in Asian medicines does not

feature (United Nations 2013). However, the treaty has exempted the use of mercury in

‘products used in traditional or religious practices’ (ibid. 2013: 22), which could arguably

include the cinnabar-containing drugs of Asian medical traditions.

Toxicology studies situated around chemical industry-funded ‘special interest science’

(SIS) show that enormous political and economic interests are at play in the struggle to define

toxicity. In studying these, we should remember that our concepts of risk and safety are not

universally shared.

Conclusion

The demand for Asian medicines and health tonics is enormous, and the markets for them are

profitable. The consumer wants to be ‘safe’ taking these drugs, especially after the increase in

published reports on toxicity. Pre-clinical safety evaluations are generally performed for new

medicinal herbal products following the standards set by respective governments. Such safety

standards have been extensively outlined by the WHO for herbal medicines, but not for the


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use of metals in ‘traditional medicine.’ How can medical anthropologists study these issues

with research methods specific to anthropology in the absence of laboratories and biomedical

testing tools? I can see several avenues.

Medical anthropologists could look more directly at the material substances of

pharmacology, write ethnographies of the use of such substances, and analyse their links to

issues of safety and toxicity. Ethnographic studies offer more nuanced approaches to better

embrace the interplay between the biomedical-pharmacological-material worlds of the

substances themselves and their socio-cultural, economic and political aspects. They thus

elucidate how substance classifications are as culturally specific as are their manufacturing

techniques, and they highlight the perceptions of the substances’ potential toxicity and the

assessments of their physiological efficacy.4 Risk studies have already made some use of

ethnographic methods to assess the cultural and religious meanings behind heavy metal use

(Riley et al. 2006).

Ethnographic research questions on potentially toxic pharmacological substances

could include, for example: How do Asian pharmacologists reason about the safety of

substances that from a biomedical perspective are considered toxic? When is a substance

considered ‘toxic,’ and when is it ‘safe’? On what pharmacological and physiological

principles are their processing methods based? I have tried to show that the understanding of

what makes a substance ‘toxic’ depends on many things, including issues of contamination,

substitution and dosage, interaction with other medicines, ‘traditional’ processing methods,

commodification and economic expansion, and also the political issues involved in WHO and

UN safety efforts.

4 With regard to herbal drugs, such culture-specific changes in preparation and therapeutic outcomes across

history have been described, for example, for the herb Artemisiae annuae in Chinese materia medica (Hsu

2014).


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To document and analyse how pharmacologists of Asian medicines define and

explain toxicity, the physiological efficacy of potentially toxic ingredients, and how

governments and the pharmaceutical industry direct and fund toxicology studies will be an

important contribution to the debate on safety studies relating to Asian medicines. In my

current research project, I show that what is considered a dug in Tibetan medicine is by

definition not simply ‘toxic.’ In this way, anthropological studies of both ‘toxicity’ and

‘toxic’ substances as such can contribute considerably to a more nuanced understanding of

Asian pharmacological practices and to safety debates on Asian medicines.

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Moving from efficacy to safety: A changing focus in the study of Asian medical systems.

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Transcript of Moving from efficacy to safety: A changing focus in the study of Asian medical systems.